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mouton29

02/21/08 5:45 PM

#8287 RE: DewDiligence #8284

<<dose-ranging, a term generally used for phase-1 trials where the maximum dose has not yet been established>>

A quick search on clinicaltrials.gov shows 87 phase I studies, 296 phase II studies, and even 54 phase III studies describing themselves as "dose ranging."

Putting aside the semantics, I think you are saying that sometimes you do a study to determine the maximum dose before material side effects appear, whereas in other studies, you try to find the best (most therapeutic) dose -- which is not always the maximum tolerated dose. That distinction certainly makes sense, and the Leo trial is in the latter class.